Core Viewpoint - The company has successfully obtained medical device registration for its BioCyte series flow cytometers in Malaysia, marking a significant step in expanding its presence in the Southeast Asian market [1] Group 1: Product Development and Approval - The BioCyte series flow cytometers were developed by the company's subsidiary, Zhongsheng (Suzhou) Medical Technology Co., Ltd [1] - The registration number for the medical device is IVDA9463526–225393, indicating compliance with Malaysian regulatory standards [1] - The approval signifies that the product is now eligible for legal sales and use in Malaysia, enhancing the company's market opportunities [1] Group 2: Market Expansion and Strategy - The successful registration is expected to facilitate the company's expansion into the Southeast Asian market, aligning with its international development strategy [1] - The product will be marketed through a local authorized representative, TRUST DIAGNOSTICS SDN BHD, to enhance market penetration [1] - The flow cytometry technology is widely used in clinical diagnostics and research, providing support for disease diagnosis, immunology research, and drug development [1] Group 3: Regulatory Compliance - Malaysia has stringent regulatory standards for medical device approval, which the company successfully navigated by completing product testing and technical documentation submission [1] - The approval process underscores the company's commitment to meeting local regulatory requirements [1]
中生北控生物科技(08247)附属中生医疗自主研发的BioCyte 系列流式细胞仪获发马来西亚医疗器械注册证